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Upper Eyelid Implant Platinum/Iridium
FDA UDIClass II (US FDA UDI)
by Heinz Kurz
Identity
- Trade Name
- Upper Eyelid Implant Platinum/Iridium FDA UDI
- Generic Name
- Eyelid weight, implantable FDA UDI
- Device Name
- Eyelid weight, implantable FDA UDI
- Model / Reference
- 4007002 FDA UDI
- Description
- Eyelid weight, implantable FDA UDI
Identifiers
- Catalog Number
- 4007002 FDA UDI
- Primary DI / UDI-DI
- EHKM40070021 FDA UDI
- 510(k) Number
- K011115 FDA UDI
- FDA Product Code
- MML FDA UDI
- GMDN Term
- Eyelid weight, implantable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.5700 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Eyelid weight, implantable
Upper Eyelid Implant Platinum/Iridium by Heinz Kurz — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Eyelid weight, implantable.
- ThinProfile Gold Eyelid Weight Implant — MEDDEV CORPORATION · Class II
- OCULID PLATINUM SLIM® 1, 4 g — FCI S A S FCI 20 22 · Class II
- OCULID GOLD 1, 4g — FCI S A S FCI 20 22 · Class II
- OCULID GOLD 0.6g — FCI S A S FCI 20 22 · Class II
- Labtician Lid Load™ 1.4 grams — Labtician Ophthalmics, Inc · Class II
- Contour Gold Eyelid Weight Implant — MEDDEV CORPORATION · Class II
- Labtician Lid Load™ 2.0 grams — Labtician Ophthalmics, Inc · Class II
- Tantalum Weight 2.2 gram Pink — Labtician Ophthalmics, Inc · Class II
Cleared under the same submission
K011115 also covers:
- Upper Eyelid Implant Platinum/Iridium — Heinz Kurz
- Upper Eyelid Implant Platinum/Iridium — Heinz Kurz
- Upper Eyelid Implant Platinum/Iridium — Heinz Kurz
- Upper Eyelid Implant Platinum/Iridium — Heinz Kurz
- Upper Eyelid Implant Platinum/Iridium — Heinz Kurz
- Upper Eyelid Implant Platinum/Iridium — Heinz Kurz
- Upper Eyelid Implant Platinum/Iridium — Heinz Kurz
- Upper Eyelid Implant Platinum/Iridium — Heinz Kurz
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Heinz Kurz
Sources (1)
- FDA UDI fd37eb6e-b2d4-4436-b9c1-e97110a8bdb9 36 fields · synced Jun 8, 2026